Optimised Lung Cancer Screening to Prevent Cardiovascular and Pulmonary Diseases Coupled With Primary Prevention (SMAC-1)

Istituto Clinico Humanitas

Status: Unknown

Conditions: Cardiovascular Disease (CVD); Lung Cancer; Chronic Obstructive Pulmonary Disease (COPD)

Study type: Observational

Funder types: Other

Identifiers

NCT04315766

2123

Details and patient eligibility

About

This project aims to implement a health prevention program for smokers or former smokers including early detection of lung cancer, cardiovascular disease (CVD) and chronic obstructive pulmonary disease (COPD). The clinical activity is completed by a pre-clinical evaluation of molecular bio-markers of early diagnosis of these diseases, with the aim of strengthening the sensitivity and specificity of the screening program.

The project also includes a cost-effectiveness assessment to validate the feasibility of the program.

Since lung cancer, CVD and COPD are among the deadliest smoking-related pathologies, the program includes actions aimed at raising awareness among primary care physicians, increasing the smoking cessation rate of participating subjects to improve quality of life.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥ 55 years old and exposure to smoking more than 30 packs-year; which corresponds to 6-year risk of lung cancer, calculated according to the plco score (≥ 2%).
• Smoker or former smoker Former smokers must have ceased smoking within the 15 years prior to enrollment in the study.
• Absence of symptoms of lung cancer such as worsening of cough, hoarseness, hemoptysis and weight loss.

Exclusion criteria

• Previous diagnosis of lung cancer.
• Positive extrapulmonary cancer history in the last 5 years (excluding in situ tumors or skin epidermoid tumor).
• Performing a chest CT scan in the last 18 months.
• Severe lung or extrapulmonary diseases that may preclude or invalidate appropriate therapy in case of diagnosis of malignant pulmonary neoplasia.